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Trial record 1 of 1 for:    NCT02507505
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Regional Versus General Anesthesia for Promoting Independence After Hip Fracture (REGAIN)

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ClinicalTrials.gov Identifier: NCT02507505
Recruitment Status : Recruiting
First Posted : July 24, 2015
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The purpose of this study is to find out if two types of standard care anesthesia are the same or if one is better for people who have hip fractures.

Condition or disease Intervention/treatment Phase
Hip Fractures Procedure: Regional Anesthesia Procedure: General Anesthesia Not Applicable

Detailed Description:

Hip fracture is a clinical condition that involves a break in the femur (hip bone) near where it attaches to the pelvis. Hip fractures occur more than 300,000 times each year in the US and over 1.6 million times each year worldwide.

Over 90% of hip fractures occur in individuals aged 50 or older, most commonly resulting from low-energy traumatic injuries, such as falls from standing in the context of established osteoporosis, chronic illness, or disability. Surgical treatment, via fixation of the fractured bone or partial or total replacement of the hip joint, is indicated for all types of hip fractures and approximately 95% of hip fracture patients undergo surgery.

No evidence-based interventions now exist to improve functional outcomes after hip fracture surgery beyond the immediate postoperative period. Nearly all hip fracture patients require orthopedic surgery and anesthesia,making the anesthetic care episode a major opportunity to impact outcomes.

Spinal and general anesthesia represent the two standard care approaches to anesthesia for hip fracture surgery. Basic and clinical research has identified multiple plausible mechanisms by which spinal anesthesia may improve outcomes after hip fracture; nonetheless, major guidelines and systematic reviews have identified key evidence gaps and anesthesia care for hip fracture varies markedly in practice. While spinal and general anesthesia for hip fracture have been previously compared in retrospective studies and small randomized trials, much of the available prospective trial data is old and may not be reflective of current clinical practice.

REGAIN will be the first pragmatic multicenter prospective randomized trial of spinal versus general anesthesia for hip fracture surgery designed to evaluate the association of anesthesia technique with functional recovery after hip fracture. As such, it will fill critical evidence gaps to inform policy and practice.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Regional Versus General Anesthesia for Promoting Independence After Hip Fracture
Study Start Date : February 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Regional Anesthesia
Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia.
Procedure: Regional Anesthesia
Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.
Other Name: Regional Block or Spinal Block

Active Comparator: General Anesthesia
Approximately half of the subjects will be randomized to the arm which receives General Anesthesia.
Procedure: General Anesthesia
General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Other Name: General Endotracheal Anesthesia




Primary Outcome Measures :
  1. Recovery of ambulation [ Time Frame: Approximately 60 days after Randomization ]

Secondary Outcome Measures :
  1. Overall health and disability [ Time Frame: Approximately 60, 180, and 365 days after randomization ]
    Will be assessed via the World Health Organization Disability Assessment Schedule (WHODAS)

  2. Ability to return to the pre-fracture place of residence [ Time Frame: Approximately 60, 180, and 365 days after randomization ]
    Will be assessed via telephone interview

  3. Chronic Pain [ Time Frame: Approximately 60, 180, and 365 days after randomization ]
    Will be assessed via the Numeric Rating Scale (NRS)

  4. Cognitive Function [ Time Frame: Baseline and approximately 60, 180, and 365 days after randomization ]
    Will be assessed via Short Blessed Test



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically or radiographically diagnosed intracapsular or extracapsular hip fracture
  • Planned surgical treatment via hemiarthroplasty, total hip arthroplasty or appropriate fixation procedure
  • Ability to walk 10 feet or across a room without human assistance before fracture

Exclusion Criteria:

  • Planned concurrent surgery not amenable to spinal anesthesia
  • Absolute contraindications to spinal anesthesia
  • Periprosthetic fracture

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507505


Contacts
Contact: Lakisha Gaskins, MHS (215) 746-6094 regain@lists.upenn.edu

  Show 45 Study Locations
Sponsors and Collaborators
University of Pennsylvania
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Mark D Neuman, MD, MSc University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02507505     History of Changes
Other Study ID Numbers: 822632
PCORI-1406-18876 ( Other Grant/Funding Number: PCORI )
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs